NCT02765347已完成4 期
The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM: A Randomized, Cross-over, Prospective Study
Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus;
- •Tanner sexual maturation rating 2-5;
- •HbA1c levels: 7.5%-10%;
- •MDI or CSII ≥6 months;
- •Insulin dose ≥ 0.8U/kg before the enrollment，and the dosage is stable at least >1 month（dosage change<10%）.
排除标准
- •Serious acute and chronic complications associated with diabetes;
- •Repeated and serious hypoglycemia episodes repeatedly;
- •Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range);
- •Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR<60ml/min/1.73m2);
- •Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III~IV;
- •Female patients who have a sex life and are not willing to use contraceptive methods;
研究组 & 干预措施
Metformin and Insulin
Other
MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g bid or tid) for 24 weeks
干预措施: Metformin (Drug)
Insulin
Other
Accept insulin for 24 weeks
干预措施: Insulin (Drug)
结局指标
主要结局
HbA1c
时间窗: half one year
次要结局
未报告次要终点
研究者
Wen Xu
Associated Professor
Third Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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